Increased Use of Checklists in Compliance Investigations

by Polsinelli


            Every day, people rely on highly skilled professionals to recall from memory a litany of information which helps them assess conditions, use their judgment, and respond accordingly.  It should come as no surprise then, that pilots and surgeons (as well as a host of other professionals) rely heavily on the use of checklists to perform critical tasks.  Recently, in-house legal and compliance departments are doing the same for compliance investigations.

Checklists Are Powerful

            In “The Checklist Manifesto: How to Get Things Right,” surgeon Atul Gawande, made a compelling case for the expanded use of checklists in health care.  Gawande explains that “checklists defend anyone, even the experienced, in many more tasks than we realized.  They provide a kind of cognitive net.  They catch mental flaws inherent in all of us-flaws of memory and attention and thoroughness.  And because they do, they raise wide, unexpected possibilities.” 

            As an example, Gawande described a hospital that implemented a five item checklist in its ICUs which resulted in a decrease in central line infections by 66%.  Gawande concluded that the checklist saved the hospitals $175 million and prevented an estimated 1500 patient deaths.

            Consider hero pilot “Sully” Sullenberger, who landed US Airways Flight 1549 on the Hudson River in January 2009.  Sullenberger has been unabashed about the importance of using checklists. When his plane lost both engines shortly after take-off, Sullenberger reflexively ordered his co-pilot to begin working through the appropriate checklist for the situation they were facing.  Sullenberger later explained that: “Checklists are a simple, inexpensive intervention that can formalize best practices when used properly—with leadership, team skills and in the appropriate culture.”

Expanded Use of Checklists in Legal and Compliance Settings   

            Checklists are now being used to assist Legal or Compliance personnel with compliance investigations.  

            Many compliance investigations involve complicated subject matter and a high level of stress.  A typical compliance investigation involves multiple data sources, multiple witnesses and a complex set of rules and regulations.  Compliance officers often use a checklist to help ensure that all appropriate sources of information are considered.

            Compliance investigations often involve issues that have the potential to be significant and the sanctions that can flow from noncompliance are enormous.  Given the stakes, lawyers and compliance officers use checklists to avoid preventable mistakes or missteps during the investigative process.  

            A checklist-based process also reduces the emotion and stress that comes with compliance investigations.  Compliance investigations involve complaints of deliberate wrongdoing so emotions can run high.  Compliance officers have found that using a checklist can help reduce unwarranted emotional reactions because the checklist “normalizes” the process.   

            A checklist increases consistency and coordination, especially when a compliance investigation is being conducted by multiple individuals. Rarely do compliance officers work in a silo when conducting an investigation.  Reviews necessarily require information and assistance from legal, financial, clinical, and administrative personnel, not to mention the other compliance personnel who are likely to be involved.  Through its delineation of the steps when conducting an investigation, the checklist promotes effective communication and interaction.      

            In addition to improving the compliance investigation itself, a checklist is incredibly valuable in documenting and explaining the process after it is complete.  Inherent in every compliance investigation is the potential for a government review and the need to respond to questions about the compliance investigation process.  Needing to explain and justify why certain actions were taking during an investigation is the stuff nightmares are made of.  Compliance officers have learned that using a checklist helps document the process and protects all involved if the government tries to second-guess the investigation.

            Given the number of problems that a checklist can solve, we likely will be seeing checklists used as part of compliance investigations for the foreseeable future.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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